The Role of Biological Risk Management in Medical Device Development

The biological evaluation is part of the conformity assessment of a medical device with the requirements of Regulation (EU) 2017/745. It starts during the development of the medical device and continues throughout its life cycle. The associated series of standards is the ISO 10993 series. It offers practical guidance for implementing the requirements for the biological evaluation and biological safety testing.

ISO 10993-1:2018 „Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process” requires that the biological evaluation should be integrated into the risk management process. ISO 10993-1 provides practical guidance for this, particularly in its Annex B. It is closely based on ISO 14971, which describes the risk management process. In addition, the requirement for an assessment of the biological (toxicological) risks of a medical device is also emphasized by ISO 10993-17, which provides practical guidance for its implementation. An important aspect of carrying out a thorough risk assessment is to consider whether existing data can be used to confirm the biological safety of the device under evaluation in order to avoid unnecessary testing (particularly from an animal welfare perspective).

Everyday practice shows that the implementation of the biological risk assessment is a challenge for many manufacturers of medical devices. In practice, there is often too little information about biological risks in both the biological evaluation report and the risk management report. The causes for this are many fold. In our opinion, one reason could be that these two processes are not sufficiently linked to one another and therefore there is no comprehensive consideration. In short, the biological experts are usually not risk management experts and vice versa and are therefore often overwhelmed by the comprehensive consideration.

A comprehensive approach would therefore be advisable. Qserve brings together experts from the fields of biological safety and risk management. We are happy to help our clients with a comprehensive view and assessment of their biological risks and their integration into the risk management system. Some of the questions we consider include:

  • What are the biological hazards?
  • What is the best way to structure them?
  • What are the risks that can be derived from them?
  • How can hazards and risks best be quantified?

The goal should be to choose an approach for the biological risk assessment that can be used sensibly from both a risk management perspective (ISO 14971) and a biological assessment perspective (ISO 10993). For example, the biological hazards should be built into the risk analyses in the usual way per ISO 14971; a biological risk assessment can then be performed (per ISO 10993-1) to determine what (biocompatibility) endpoints need to be used and what data are sufficient to meet those endpoints. In this way, uniform information can be presented in a well-structured manner in both the risk management report and the biological evaluation report. A well-designed biological risk assessment provides an important basis for determining the necessary biological safety testing as well as a general basis for assessing the safety of the medical device.

If you have any questions about the biological safety evaluation and its integration into the risk management process, please feel free to contact our experts.

Dr. Stéphane Naudin
Post date: April 02, 2024
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